Clinipace Worldwide, a global digital clinical research organization
(dCRO), announced today that Phosphate Therapeutics, co-owned and resourced by Shield Therapeutics
(Shield), an independent specialty pharmaceutical company, has selected the company to manage its first pivotal trial in its late stage Nephrology program expected to commence in 2014.
Clinipace will manage a pivotal trial of PT20
, a novel iron-based phosphate binder being developed for the treatment of hyperphosphataemia related to chronic kidney disease (CKD).
Hyperphosphataemia is a life-threatening complication of CKD, the incidence of which is increasing globally as obesity and diabetes levels rapidly rise. The treatment of this condition is a significant unmet medical need, providing a strategic opportunity for Phosphate and Clinipace to partner in research.
“Given the gravity of the disease under study, and significant therapeutic promise shown by PT20 in early research, it was crucial for us to work with a provider that could help us complete this pivotal study quickly and effectively in order to reduce the development risk associated with the PT20 programme. We look forward to working with Clinipace on this important study,” said Julian Howell, Group Medical Director, Phosphate Therapeutics Ltd.
“With the rising incidence and prevalence of kidney disease, poor outcomes and high costs associated with treatment are putting undue burdens on the global healthcare system,” said Jeff Williams, CEO, Clinipace Worldwide. “With much of the expense of bringing promising drugs like PT20 to market related to the cost of clinical trials, we offer not only an experienced, therapeutically-focused team but a technology-enabled services approach, our dCRO model, to ensure the trial is optimized for budget and visibility while it is being conducted.”